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Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes

NCT07550608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-30

No results posted yet for this study

Summary

The Purpose of the Study The purpose of this study is to compare how blood sugar levels change during exercise in men and women with type 1 diabetes (T1D). Researchers want to understand if biological sex affects the risk of low blood sugar (hypoglycemia) during physical activity. Additionally, the study examines whether reducing the background (basal) insulin dose before exercise is effective at keeping blood sugar stable.

Study Population The study includes active adults (men and women) aged 18-45 who have lived with type 1 diabetes for at least 18 months and use an insulin pump.

What Happens During the Study

Participants complete three laboratory visits:

Visit 1: A fitness test on a treadmill to measure the participant's aerobic capacity.

Visits 2 \& 3: Two 60-minute moderate-intensity exercise sessions on a treadmill.

In one session, participants reduce their basal insulin by 50% starting 90-120 minutes before exercising.

In the other session, they maintain their usual insulin dose.

Researchers measure blood sugar every 10 minutes during exercise and collect blood samples before and after the sessions to monitor hormone levels.

Study Design This is a randomized crossover study, meaning every participant performs both exercise strategies in a random order to serve as their own control.

Conditions

Interventions

OTHER

50% Pre-Exercise Basal Insulin Rate Reduction (BIRR)

Participants are instructed to reduce their habitual basal insulin infusion rate by 50% using their continuous subcutaneous insulin infusion (CSII) pump. This reduction is initiated 90 to 120 minutes prior to the start of the 60-minute moderate-intensity treadmill exercise bout. The intervention is designed to evaluate if this proactive reduction mitigates the risk of exercise-induced hypoglycemia in both male and female recreational athletes with type 1 diabetes.

OTHER

Habitual Basal Insulin Rate Maintenance

Participants perform a 60-minute moderate-intensity treadmill exercise bout while maintaining their full habitual basal insulin infusion rate as programmed in their CSII pump. No adjustments, reductions, or suspensions of the basal rate are made prior to or during the exercise session. This condition serves as the active comparator to evaluate standard glucose dynamics without anticipatory insulin manipulation.

Sponsors & Collaborators

  • Naama Constantini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550608 on ClinicalTrials.gov